Sodium Polystyrene Sulfonate

Kionex® brand of sodium polystyrene sulfonate is a benzene, diethenyl- polymer with ethenylbenzene, sulfonated, sodium salt and has the following structural formula:

The drug is a cream to light brown finely ground, powdered form of sodium polystyrene sulfonate, a cation-exchange resin prepared in the sodium phase with an in vitro exchange capacity of approximately 3.1 mEq (in vivoapproximately 1 mEq) of potassium per gram. The sodium content is approximately 100 mg (4.1 mEq) per gram of the drug. It can be administered orally or in an enema.

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

• Importance of informing patients that it may be advisable to administer other oral drugs ≥6 hours before or 6 hours after oral administration of sodium polystyrene sulfonate.105

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.107 108

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.107 108

• Importance of informing patients of other important precautionary information.107 108 (See Cautions.)

Take sodium polystyrene sulfonate only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

sodium polystyrene sulfonate comes as a liquid suspension and as a powder that is mixed with water or syrup. If you or your child are not able to swallow the liquid, the medicine can be put in the stomach with a special tube. Talk to your doctor if you have questions about this.

Your doctor will tell you how to mix the powder with water or syrup. Each dose of the powder must be mixed with a liquid right before you take it. Stir the powder mixture to dissolve the medicine. Do not store the liquid mixture to take later.

Measure the liquid suspension with a marked measuring spoon, oral syringe, or medicine cup. Shake the bottle of medicine well just before taking each dose.

Dosing

The dose of sodium polystyrene sulfonate will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of sodium polystyrene sulfonate. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (powder, suspension):
  • For treatment of hyperkalemia:
    • Adults—15 grams one to four times a day.
    • Children and infants—Dose is based on potassium blood level and must be determined by your doctor.

Missed Dose

If you miss a dose of sodium polystyrene sulfonate, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

As the resin passes along the intestine or is retained in the colon after administration by enema, the sodium ions are partially released and are replaced by potassium ions. For the most part, this action occurs in the large intestine, which excretes potassium ions to a greater degree than does the small intestine. The efficiency of this process is limited and unpredictably variable. It commonly approximates the order of 33 percent but the range is so large that definitive indices of electrolyte balance must be clearly monitored.

Metabolic data are unavailable.

Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Sodium Polystyrene Sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (see PRECAUTIONS, Drug Interactions).

• Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery.
• Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction).
• Discontinue use in patients who develop constipation.

Since effective lowering of serum potassium with Sodium Polystyrene Sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Serious potassium deficiency can occur from therapy with Sodium Polystyrene Sulfonate. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Sodium Polystyrene Sulfonate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Like all cation-exchange resins, Sodium Polystyrene Sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Sodium Polystyrene Sulfonate should be monitored for all applicable electrolyte disturbances.

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Sodium Polystyrene Sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Sodium Polystyrene Sulfonate with magnesium hydroxide as laxative. (See PRECAUTIONS, Drug Interactions.)

Cases of intestinal necrosis, which may be fatal, and other serious gastrointestinal adverse events (bleeding, ischemic colitis, perforation) have been reported in association with Sodium Polystyrene Sulfonate use. The majority of these cases reported the concomitant use of sorbitol. Risk factors for gastrointestinal adverse events were present in many of the cases including prematurity, history of intestinal disease or surgery, hypovolemia, and renal insufficiency and failure. Concomitant administration of sorbitol is not recommended (see PRECAUTIONS, Drug Interactions).

• Use only in patients who have normal bowel function. Avoid use in patients who have not had a bowel movement post-surgery.
• Avoid use in patients who are at risk for developing constipation or impaction (including those with history of impaction, chronic constipation, inflammatory bowel disease, ischemic colitis, vascular intestinal atherosclerosis, previous bowel resection, or bowel obstruction).
• Discontinue use in patients who develop constipation.

Since effective lowering of serum potassium with Sodium Polystyrene Sulfonate may take hours to days, treatment with this drug alone may be insufficient to rapidly correct severe hyperkalemia associated with states of rapid tissue breakdown (e.g., burns and renal failure) or hyperkalemia so marked as to constitute a medical emergency. Therefore, other definitive measures, including dialysis, should always be considered and may be imperative.

Serious potassium deficiency can occur from therapy with Sodium Polystyrene Sulfonate. The effect must be carefully controlled by frequent serum potassium determinations within each 24 hour period. Since intracellular potassium deficiency is not always reflected by serum potassium levels, the level at which treatment with Sodium Polystyrene Sulfonate should be discontinued must be determined individually for each patient. Important aids in making this determination are the patient's clinical condition and electrocardiogram. Early clinical signs of severe hypokalemia include a pattern of irritable confusion and delayed thought processes.

Electrocardiographically, severe hypokalemia is often associated with a lengthened Q-T interval, widening, flattening, or inversion of the T wave, and prominent U waves. Also, cardiac arrhythmias may occur, such as premature atrial, nodal, and ventricular contractions, and supraventricular and ventricular tachycardias. The toxic effects of digitalis are likely to be exaggerated. Marked hypokalemia can also be manifested by severe muscle weakness, at times extending into frank paralysis.

Like all cation-exchange resins, Sodium Polystyrene Sulfonate is not totally selective (for potassium) in its actions, and small amounts of other cations such as magnesium and calcium can also be lost during treatment. Accordingly, patients receiving Sodium Polystyrene Sulfonate should be monitored for all applicable electrolyte disturbances.

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Sodium Polystyrene Sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Sodium Polystyrene Sulfonate with magnesium hydroxide as laxative. (See PRECAUTIONS, Drug Interactions.)

Systemic alkalosis has been reported after cation-exchange resins were administered orally in combination with nonabsorbable cation-donating antacids and laxatives such as magnesium hydroxide and aluminum carbonate. Magnesium hydroxide should not be administered with Sodium Polystyrene Sulfonate. One case of grand mal seizure has been reported in a patient with chronic hypocalcemia of renal failure who was given Sodium Polystyrene Sulfonate with magnesium hydroxide as laxative. (See PRECAUTIONS, Drug Interactions.)

NDC 42808-500-16         Rx Only

Sodium Polystyrene
Sulfonate, USP

Read Package Outsert

Average adult dose: 15 g (approximately 4 level Teaspoons) one to four times
daily in water. See complete prescribing information.

The effect must be carefully controlled by frequent serum potassium determinations within
each 24 hour period. Sodium content approximately 60 mEq per 15 g.

Suspension should be freshly prepared and not stored beyond 24 hours.
Dispense in tight, light-resistant containers as defined in the official compendia.

Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F) [see USP Controlled Room Temperature]

Manufactured for Exact-Rx, Inc., Melville, NY 11747

Exact-Rx.
Incorporated®

453.6 grams (1 lb)

• Kalexate [DSC]
• Kayexalate
• Kionex
• SPS

Do not mix in orange juice or in any fruit juice known to contain potassium. Some products may contain sodium.

Aluminum Hydroxide: Sodium Polystyrene Sulfonate may enhance the adverse/toxic effect of Aluminum Hydroxide. More specifically, concomitant use of these agents may increase the risk for intestinal obstruction. Management: Monitor for signs/symptoms of intestinal obstruction with concomitant use of calcium polystyrene sulfonate and aluminum hydroxide. Adequate fluid intake, laxative use, alternative antacid agents, and/or limiting duration of therapy may help reduce risks. Consider therapy modification

Antacids: May enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. The combined use of these two agents may result in metabolic alkalosis and/or loss of efficacy of the exchange resin. Management: To minimize this interaction, consider: a)separating doses by 2 or more hours; b)rectal administration of the exchange resin; or c)alternatives to antacids. Monitor for metabolic alkalosis and attenuation of SPS effects. Avoid magnesium hydroxide. Exceptions: Sodium Bicarbonate. Consider therapy modification

Digoxin: Sodium Polystyrene Sulfonate may enhance the adverse/toxic effect of Digoxin. Monitor therapy

Laxatives (Magnesium Containing): May enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of sodium polystyrene sulfonate with magnesium-containing laxatives may result in metabolic alkalosis or with sorbitol may result in intestinal necrosis. Management: Avoid concomitant use of sodium polystyrene sulfonate (rectal or oral) and magnesium-containing laxatives. Avoid combination

Lithium: Sodium Polystyrene Sulfonate may decrease the serum concentration of Lithium. Management: Consider separating administration of lithium from administration of oral sodium polystyrene sulfonate by at least 6 hours. Consider therapy modification

Meloxicam: May enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of meloxicam oral suspension (which contains sorbitol) may increase the risk for intestinal necrosis. Avoid combination

Sorbitol: May enhance the adverse/toxic effect of Sodium Polystyrene Sulfonate. More specifically, concomitant use of these agents may increase the risk for intestinal necrosis. Avoid combination

Thyroid Products: Sodium Polystyrene Sulfonate may decrease the serum concentration of Thyroid Products. Management: To minimize risk of interaction, separate dosing of oral sodium polystyrene sulfonate and thyroid products (e.g., levothyroxine) or administer sodium polystyrene sulfonate rectally. Monitor for signs/symptoms of hypothyroidism with concomitant use (oral). Consider therapy modification

Animal reproduction studies have not been conducted. Sodium polystyrene sulfonate is not absorbed systemically following oral or rectal administration. Use during pregnancy is not expected to result in significant exposure to the fetus.